o improve the disclosure process, we have concluded that the initial submission must contain the following information:

(1) a complete description ofthe conduct being disclosed;

(2) a description ofthe provider’s internal investigation or a commitment regarding when it wil be completed;

(3) an estimate of the damages to the Federal health care programs ànd the methodology used to calculate that figue or a commitment regarding when the provider will complete such estimate; and

(4) a statement of the laws potentially violated by the conduct.

This information must be included in addition to the Basic Information described in the SDP. The provider must be in a position to complete the investigation and damages assessment within 3 months after acceptance into the SDP.

HHS Office of the Inspector General, An Open Letter to Health Care Providers: April 15, 2008

The OIG has announced changes to its Self-Disclosure Protocol. The OIG notes that “cooperative self-disclosers” may avoid or mitigate integrity sanctions.

The text of the news release accompanying this letter –

Washington, DC — Inspector General Daniel R. Levinson issued An Open Letter to Health Care Providers today announcing that the Office of Inspector General (OIG) for the Department of Health and Human Services has refined the requirements of the OIG Provider Self-Disclosure Protocol, under which health care providers can voluntarily
report fraudulent conduct affecting Medicare, Medicaid, and other Federal health care programs.

The Self-Disclosure Protocol provides guidance to health care providers who voluntarily disclose Federal health care program compliance issues that the provider believes potentially violate Federal criminal, civil, or administrative laws for which exclusion or civil monetary penalties are authorized. According to the Open Letter, providers who disclose in good faith, fully cooperate with OIG, and provide requested information in a timely manner will generally not be required to enter into Corporate Integrity or Certification of Compliance Agreements with OIG.

“A provider’s submission of a complete and informative disclosure, quick response to OIG’s requests for further information, and performance of an accurate audit are indications that the provider has adopted effective compliance measures,” said Inspector General Levinson. “Accordingly, when we negotiate the resolution of OIG’s applicable
administrative monetary and permissive exclusion authorities in exchange for an appropriate monetary payment, we generally will not require the provider to enter into a Corporate Integrity Agreement or Certification of Compliance Agreement. We believe this presumption in favor of not requiring a compliance agreement appropriately recognizes the provider’s commitment to integrity and also advances our goal of expediting the resolution of self-disclosures.”

The Open Letter also sets forth four additional Self-Disclosure submission requirements and emphasizes OIG’s commitment to streamline its internal process for self-disclosure case resolution. To read An Open Letter to Health Care Providers, go to: http://oig.hhs.gov/fraud/docs/openletters/OpenLetter4-15-08.pdf.